AXSOS 661155Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252580195), received between Jun 24, 2019 and Jun 24, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2019Defective Device; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN AXSOS PLATE AND SCREWS APPROXIMATELY 1 YEAR AGO. THE PATIENT ALSO HAD AN EXPANDABLE (NON-STRYKER) PLATE IMPLANTED. THIS EXPANDABLE PLATE STOPPED WORKING, SO THE SURGEON DECIDED TO REVISE AND UPON X-RAY (B)(6)2019 HE NOTICED THAT 3 AXSOS LOCKING SCREWS HAD BACKED OUT OF THE PLATE. THE PATIENT WAS REVISED BECAUSE OF THE EXPANDABLE PLATE, NOT THE STRYKER LOCKING SCREWS. NEW INFORMATION RECEIVED: ¿ IT WAS COMPETITOR EXPANDABLE NAIL PRECICE NAIL RETROGRADE ¿ IT WAS NOTED PLATE BENT A LOT DURING TRANSPORTATION BUT NO ISSUES REPORTED UNTIL IT WAS NOTED SCREWS HAD BECOME ¿UNLOCKED¿ THE PLATES WASN¿T REVISED BECAUSE OF THIS, IT WAS BECAUSE THE NAIL HAD STOPPED WORKING. ¿ EVENT WAS NOTED ON X RAY(B)(6)2019 ¿ THE BONE TRANSPORTATION HAS TAKEN LONGED THE EXPECTED. ¿ ORIGINAL INJURY WAS PRETTY SIGNIFICANT, HIGH ENERGY TRAUMA WITH AN OPEN DISTAL FEMORAL FRACTURE. INFORMATION RECEIVED FROM REP ON (B)(6)2019: IT¿S THE PROXIMAL END OF THE PLATE WHERE THE SCREWS BACKED OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729057 ↗